Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD

NCT06707753 | Active Not Recruiting Phase 1

• 1 other identifier: AL-001-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will receive a single dose of AL-001 administered via suprachoroidal space injection.

Conditions

Wet Age-related Macular Degeneration (wAMD)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Week 24

Secondary Outcomes (1)

• Evaluate the effect of AL-001 on BCVA

  Week 52

Study Arms (3)

AL-001 Dose 1

EXPERIMENTAL

Injection of low dose

Drug: AL-001

AL-001 Dose 2

EXPERIMENTAL

Injection of medium dose

Drug: AL-001

AL-001 Dose 3

EXPERIMENTAL

Injection of high dose

Drug: AL-001

Interventions

AL-001 DRUG

Administered via suprachoroidal space injection.

AL-001 Dose 1; AL-001 Dose 2; AL-001 Dose 3

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 50 and ≤ 80.
• The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
• Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
• The subject or their legal representative agrees to participate in this study and signs a written ICF.

You may not qualify if:

• Non-wAMD induced CNV or macular edema in the study eye.
• Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
• Uncontrolled glaucoma in the study eye.
• History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
• Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
• Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
• Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
• None of intraocular inflammation in the study eye.
• Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.

Sponsors & Collaborators

• Beijing Anlong Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: September 11, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Locations

CN (1)